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FDA Breakthrough Therapy Designation: Statistics Chart Updated (as of 02/06/15)

February 13, 2015

 

 

The CBER BTD #s are current as of 01/31/15 and the CDER BTD #s are current as of 02/06/15.

The changes are as follows:

•   The total # of FDA CDER + CBER BTD Requests received by the FDA increases from 273 to 275

•   The total # of FDA CDER + CBER BTDs Granted by the FDA increases from 74 to 77

•   The total # of FDA CDER + CBER BTDs Denied by the FDA increases from 142 to 144

•   The total # of FDA CDER + CBER BTDs Pending by the FDA decreases from 57 to 54.

FDA CBER BTDs + CDER BTDs (as of 02/06/15)

Breakthrough Therapy  Designation (BTD) Category Total # of CBER Designations (07/09/12-01/31/15) Total # of CDER Designations (07/09/12-02/06/15) Total # of CBER +   CDER BTD Designations (07/09/12-02/06/15)
Total # of BTD Requests Received 46 229 275
Total # of BTDs Granted 9 68 77
Total # of BTDs   Denied 31 113 144
Total # of BTDs   Pending 6 48 54

.

OBSERVATIONS

•   28.0 % of the total # of BTD Requests Received results in the BTD being granted

•   52.4 % of the total # of BTD Requests Received results in the BTD being denied

•   19.6 % of the total # of BTD Requests Received results in the BTD pending.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

Copyright © 2012-2015, Orphan Druganaut Blog. All rights reserved.

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